Effect of Fermentable Carbohydrate on Glucose Homeostasis

NCT01841073 | Completed Results

• 1 other identifier: FermCarb
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

The rise in the prevalence of type 2 diabetes is related to recent lifestyle changes leading to a rise in obesity. Obesity is a risk factor for Impaired Glucose Tolerance (IGT) and diabetes. A type of fibre - fermentable carbohydrate - may help prevent diabetes in individuals with IGT by reducing appetite and food intake, and improving insulin sensitivity. Although fermentable carbohydrate is not absorbed in the small intestine it is full fermented by the colonic bacteria. The fermentation of this carbohydrate produces short chain fatty acids which act on specific G protein coupled receptors (GPR41/43) in the intestine to release GLP-1 and PYY. GLP-1 and PYY are hormones which act on appetite centres in the brain to decrease appetite. GLP-1 incretin effects and possible effect of the beta cell will increase insulin sensitivity. Short chain fatty acids also suppress the release of free fatty acids from adipocytes. Lower levels of free fatty acids in insulin resistant subject's leads to improved insulin sensitivity. This body of work will examine the effect of fermentable carbohydrate on appetite, weight loss, blood glucose control which will give an indication of the possibility of fermentable carbohydrate to prevent type 2 diabetes in this at-risk group.

Conditions

Prediabetes

Keywords

Prediabetes; Fermentable carbohydrate; Appetite; Glucose homeostasis; Weight management

Outcome Measures

Primary Outcomes (1)

• Glycaemic Control

  An oral glucose tolerance test (OGTT) using 75 g of glucose was performed to clarify glycaemic status.

  9 weeks

Secondary Outcomes (1)

• Food Intake in Gram at 9 Weeks

  9 weeks

Other Outcomes (1)

• Percentage Change in Body Weight

  9 weeks

Study Arms (2)

Inulin

EXPERIMENTAL

Subject will take 10g inulin for 2 weeks, 20g of inulin for the next 2 weeks and then 30g for the remainder of the investigations.

Dietary Supplement: Inulin

Cellulose

PLACEBO COMPARATOR

Subjects will take 10g cellulose a day for 2 weeks, followed by 20g a day for 2 weeks, then 30g a day for the rest of the study.

Dietary Supplement: Cellulose

Interventions

Inulin DIETARY_SUPPLEMENT

Subjects will have 4 dietary counselling sessions in the first 9 weeks of the study with a goal to lose 5% of their body weight by week 9. They will be asked to maintain their weight loss until week 18.

Also known as: Synergy1

Inulin

Cellulose DIETARY_SUPPLEMENT

Subjects will have 4 dietary counselling sessions in the first 9 weeks of the study with a goal to lose 5% of their body weight by week 9. They will be asked to maintain their weight loss until week 18.

Cellulose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Investigation 1 and 3: An oral glucose tolerance test diagnostic of impaired glucose tolerance as defined by the WHO as a fasting plasma glucose\<7.0mmol/l and a 2-h plasma glucose ≥7.8 and \<11.1mmol/l and/or impaired fasting glucose, defined by the American Diabetes Association as a fasting plasma glucose of \>5.6 and \<6.9mmol/L.
• Investigation 2: An oral glucose tolerance test diagnostic of impaired glucose tolerance as defined by the WHO as a fasting plasma glucose\<7.0mmol/l and a 2-h plasma glucose ≥7.8 and \<11.1mmol/l. For investigation 2, people with only IFG will be excluded.
• All investigations:
• Adults over 18 years of age
• Males and Females with a BMI between 25-35 kg/m2. The BMI range of between 25-35Kg/m2 has been chosen as this is the range that the majority of overweight people fall into (1). At this level of overweight and obesity there is an increase in the risk of type 2 diabetes. Above 40 kg/m2 there appears to be decreased success with lifestyle advice.
• The volunteers should have given full written consent.
• Have had a stable body weight for the last 6 months with no more than a 5% change in body weight over 6 months.

You may not qualify if:

• Adults less than 18 years of age.
• Volunteers with a major metabolic disease - including diabetes.
• A normal oral glucose tolerance test or that diagnostic of diabetes by the WHO criteria.
• Pregnant and lactating women.
• Males and Females with a BMI less than 25kg/m2 or greater than 35kg/m2
• Volunteers unable to give informed consent for themselves.
• Has lost or gained 5% of their normal body weight in the last 6 months.
• Has a known/diagnosed gastrointestinal problem such as inflammatory bowel disease, irritable bowel syndrome etc
• Those with anaemia (Hb \<10g/l)
• Drug or alcohol abuse in the last 2 years.

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Imperial College London

London, W11 0NN, United Kingdom

Location

Related Publications (3)

• Guess ND, Dornhorst A, Oliver N, Frost GS. A Randomised Crossover Trial: The Effect of Inulin on Glucose Homeostasis in Subtypes of Prediabetes. Ann Nutr Metab. 2016;68(1):26-34. doi: 10.1159/000441626. Epub 2015 Nov 17.

  PMID: 26571012 RESULT

• Guess ND, Dornhorst A, Oliver N, Bell JD, Thomas EL, Frost GS. A randomized controlled trial: the effect of inulin on weight management and ectopic fat in subjects with prediabetes. Nutr Metab (Lond). 2015 Oct 24;12:36. doi: 10.1186/s12986-015-0033-2. eCollection 2015.

  PMID: 26500686 DERIVED

• Guess ND, Caengprasath N, Dornhorst A, Frost GS. Adherence to NICE guidelines on diabetes prevention in the UK: Effect on patient knowledge and perceived risk. Prim Care Diabetes. 2015 Dec;9(6):407-11. doi: 10.1016/j.pcd.2015.04.005. Epub 2015 May 13.

  PMID: 25979539 DERIVED

MeSH Terms

Conditions

Prediabetic State

Interventions

Inulin; Cellulose

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Starch; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Fructans; Polysaccharides; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Results Point of Contact

• Title: Prof Gary Frost
• Organization: Imperial College London

g.frost@imperial.ac.uk

+44 (0)20 7594 0959

Study Officials

• Gary Frost, PhD

  Imperial College London

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2013
• First Posted: April 26, 2013
• Study Start: March 1, 2011
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2014
• Last Updated: November 25, 2019
• Results First Posted: November 1, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)